NCT04636268

FIB Grifols Congenital Deficiency for On-demand Treatment and Surgical Prophylaxis

A Prospective, Multicenter, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Human Plasma-derived Fibrinogen Concentrate (FIB Grifols) in Subjects With Congenital Afibrinogenaemia and Severe Hypofibrinogenemia Requiring Either On-demand Treatment for Acute Bleeding or Surgical Prophylaxis

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Instituto Grifols, S.A. · Industry
• Sex: All
• Age: 6 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 3, multi-center, prospective, open-label, single-arm, clinical trial to be carried out in subjects with congenital fibrinogen deficiency manifested as afibrinogenemia or severe hypofibrinogenemia. This clinical trial is planned to be performed at study sites in multiple countries. It is planned to include a maximum of 32 adult and pediatric subjects with congenital fibrinogen deficiency in order to provide at least 28 evaluable acute bleeding episodes and/or surgical procedures.

Conditions

• Congenital Afibrinogenemia
• Hypofibrinogenemia

Interventions

Type	Name	Description
BIOLOGICAL	FIB Grifols	FIB Grifols is the IP and will be administered via slow intravenous (IV) infusion at a rate not to exceed 5 mL/minute. Dosing will be individually calculated for each subject based on the target plasma fibrinogen level according to the type of bleeding, measured actual plasma fibrinogen level before infusion, and body weight. The IP will be administered according to the nominal potency of the product.

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2020-11-19
• Last updated: 2023-10-23

Regulatory

• FDA-regulated drug study